Analgesia Nociception Index for Pain Monitoring in Intensive Care Units

NCT ID: NCT05313789

Last Updated: 2022-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-11

Study Completion Date

2022-06-06

Brief Summary

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The aim of this study is to examine the usability of ANI in patients who will be treated in intensive care unit.

Detailed Description

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The aim of this study is to examine the usability of Analgesia Nociception Index in patients who will be treated in intensive care unit ( a- Cardiovascular b- surgical c- internal diseases), mechanically ventilated and lacking communication. The investigators will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index.

Conditions

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Stress Related Disorder Pain Intensive Care Unit Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Intensive Care Patients (Cardiovascular)

Intensive care unit patients, mechanically ventilated and lacking communication. Will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index.

Analgesia Nociception Index (ANI)

Intervention Type DEVICE

Monitorization of Analgesia Nociception Index in Intensive Care Patients

Intensive Care Patients (Internal diseases)

Intensive care unit patients, both mechanically ventilated and lacking communication and mechanically ventilated and conscious. Will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index.

Analgesia Nociception Index (ANI)

Intervention Type DEVICE

Monitorization of Analgesia Nociception Index in Intensive Care Patients

Intensive Care Patients (Obese)

Intensive care unit patients. Will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index.

Analgesia Nociception Index (ANI)

Intervention Type DEVICE

Monitorization of Analgesia Nociception Index in Intensive Care Patients

Interventions

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Analgesia Nociception Index (ANI)

Monitorization of Analgesia Nociception Index in Intensive Care Patients

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Intensive Care Cardiovascular Patients Group 1 - Patients aged from 18 to 80 years, scheduled for elective isolated coronary bypass graft (CABG) for 2-4 vessel disease, without any perioperative complications, and who were postoperatively monitored via the analgesia nociception index in the cardiovascular intensive care will be included.
* Intensive Care Internal Diseases Group 2 - Patients aged from 18 to 80 years, intubated or tracheostomized, In mechanical ventilation with Pressure-Controlled Ventilation mode, under perfusion neuromuscular blocker, Normothermic, non-cooperative and/or sedated and neuromuscular blocker
* Intensive Care Patients (Obese) Group 3 - Post Bariatric surgery, over 40 BMI

Exclusion Criteria

* Intensive Care Cardiovascular Patients Group 1 Patients who required emergency surgery, had significant preoperative chronic pain, had autonomic nervous system anomalies and patients with rhythm will be excluded from the study.
* Intensive Care Internal Diseases Group 2 Ramsey sedation scale under 5, cooperative, with spontaneous breathing effort and extremity movement, non sinusal cardiac rhythm
* Intensive Care Patients (Obese) Group 3 - patients under 40 BMI
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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İstanbul Yeni Yüzyıl Üniversitesi

OTHER

Sponsor Role lead

Responsible Party

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Ali Sefik Koprulu, MD, Ass. Prof.

Ass. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ali Sefik Koprulu, MD

Role: CONTACT

+905322677226

Ersi Kalfoglou, PhD

Role: CONTACT

+905323500656

References

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Le Guen M, Jeanne M, Sievert K, Al Moubarik M, Chazot T, Laloe PA, Dreyfus JF, Fischler M. The Analgesia Nociception Index: a pilot study to evaluation of a new pain parameter during labor. Int J Obstet Anesth. 2012 Apr;21(2):146-51. doi: 10.1016/j.ijoa.2012.01.001. Epub 2012 Feb 21.

Reference Type BACKGROUND
PMID: 22360936 (View on PubMed)

Jeanne M, Clement C, De Jonckheere J, Logier R, Tavernier B. Variations of the analgesia nociception index during general anaesthesia for laparoscopic abdominal surgery. J Clin Monit Comput. 2012 Aug;26(4):289-94. doi: 10.1007/s10877-012-9354-0. Epub 2012 Mar 28.

Reference Type BACKGROUND
PMID: 22454275 (View on PubMed)

Dias Dde S, Resende MV, Diniz Gdo C. Patient stress in intensive care: comparison between a coronary care unit and a general postoperative unit. Rev Bras Ter Intensiva. 2015 Jan-Mar;27(1):18-25. doi: 10.5935/0103-507X.20150005. Epub 2015 Mar 1.

Reference Type BACKGROUND
PMID: 25909309 (View on PubMed)

Soral M, Altun GT, Dincer PC, Arslantas MK, Aykac Z. Effectiveness of the Analgesia Nociception Index Monitoring in Patients Who Undergo Colonoscopy with Sedo-Analgesia. Turk J Anaesthesiol Reanim. 2020 Feb;48(1):50-57. doi: 10.5152/TJAR.2019.45077. Epub 2019 Sep 24.

Reference Type BACKGROUND
PMID: 32076680 (View on PubMed)

Jendoubi A, Abbes A, Ghedira S, Houissa M. Pain Measurement in Mechanically Ventilated Patients with Traumatic Brain Injury: Behavioral Pain Tools Versus Analgesia Nociception Index. Indian J Crit Care Med. 2017 Sep;21(9):585-588. doi: 10.4103/ijccm.IJCCM_419_16.

Reference Type BACKGROUND
PMID: 28970658 (View on PubMed)

Broucqsault-Dedrie C, De Jonckheere J, Jeanne M, Nseir S. Measurement of Heart Rate Variability to Assess Pain in Sedated Critically Ill Patients: A Prospective Observational Study. PLoS One. 2016 Jan 25;11(1):e0147720. doi: 10.1371/journal.pone.0147720. eCollection 2016.

Reference Type BACKGROUND
PMID: 26808971 (View on PubMed)

Other Identifiers

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20180413.2018/04-2

Identifier Type: -

Identifier Source: org_study_id

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